BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBEROPTIC TRANSILLUMINATOR

    MDR report key: 34287 · Received July 19, 1996

    Report

    Report Number
    MW1009530
    Event Type
    Malfunction
    Date Received
    July 19, 1996
    Date of Event
    May 17, 1996
    Report Date
    July 1, 1996
    Manufacturer
    LUXTEC CORP.
    Product Code
    MQW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TRANSILLUMINATOR BEING USED ON PREMATURE NEONATE FOR IV PLACEMENT. BURN RESULTED DUE TO APPARENT MIXUP OF ELECTRICAL CABLES (GRAY CABLE ATTACHED INSTEAD OF APPROPRIATE WHITE CABLE. AGE AT TIME OF EVENT: 7 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIBEROPTIC TRANSILLUMINATOR FIBEROPTIC TRANSILLUMINATOR MQW LUXTEC CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Other